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Warwick Consulting

Medical Devices & Bioinformatics Consulting.

09/09/2026

Boston. September 9th. Doors are open and the room is filling up.

BSI and Warwick Consulting take the stage this afternoon to talk AI trust at MassMEDIC's Regulatory, Payment & Policy Conference.

Come find us if you're here today. 🤝

09/08/2026

Tomorrow.

BSI and Warwick Consulting take the stage at MassMedic's Regulatory, Payment & Policy Conference in Boston for a session on trusting AI in the regulated MedTech industry.

If you are attending, come find us, we would love to connect and hear your thoughts. If you cannot make it, we will share key moments from the event here.

Looking forward to seeing you at the event!

09/03/2026

The Keynote panel line-up is set !

On September 9th, Warwick Consulting and BSI are co-presenting a Keynote panel at the MassMEDIC Regulatory, Payment and Policy Conference in Boston to talk about "What does trustworthy AI actually mean in the MedTech Industry?"

Meet the panelists:
🎤 Moderator: Michael Metcalf, Director of Sales, Warwick Consulting
🗣️ Panelist: Samantha Sewlochan, Client Manager, AI Delivery Team, BSI
🗣️ Panelist: Johnathon Bis, Director, BSI Group America
🗣️ Panelist: Becky Legare, VP of Quality, Regulatory & Clinical, Warwick Consulting
🗣️ Panelist: Shashi Murthy, Director of Program Management, Warwick Consulting

Will you be in the audience? Drop a comment below or send us a DM, we’d love to connect before or after the session! 👇

09/02/2026

Three questions we're bringing to the MassMEDIC event on September 9th.

𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝘁𝗼 𝗮𝘁𝘁𝗲𝗻𝗱: https://na3.hubs.ly/y0BRfX0

08/28/2026

A question we're hearing more and more from MedTech leadership teams:
If a customer, auditor, regulator, or board asked you to demonstrate that your AI is safe, trustworthy, and governed responsibly today, could you?

For many organizations, the honest answer is not yet.

As AI adoption accelerates across MedTech, organizations are facing increasing pressure to demonstrate not only that their AI-enabled systems perform as intended, but that they have the governance, risk management, oversight, and evidence to support that claim.

That gap is starting to show up in places that matter:
• Deals can slow down when customers and procurement teams can't get comfortable with AI claims
• Inspections and audits become more challenging when governance and risk controls can't be demonstrated with evidence
• Leadership is asking who owns AI risk and how that risk is being managed
• Regulatory and stakeholder expectations around responsible AI continue to evolve

None of this means AI adoption should slow down. It means governance needs to keep pace with innovation.

On September 9th, Warwick Consulting and BSI (British Standards Institution) will join forces at MassMedic for a discussion on the opportunities and challenges of implementing responsible AI in the MedTech sector.

08/27/2026

This week, a first: Warwick Consulting and BSI are sharing a stage together at the MassMEDIC for Regulatory, Payment and Policy Conference on September 9th in Boston.

AI trust in MedTech has moved past a compliance conversation. Customers want evidence, not assurances. Regulators are asking sharper questions, and boards are asking who owns the risk when something goes wrong.

That's the conversation we're bringing to MassMEDIC, alongside BSI's perspective on what independent, credible evidence of trustworthy AI actually requires.

If you're attending, come find us. If you're not, we'll share what comes out of the discussion here in the weeks after.

More soon.

08/13/2026

You shouldn’t have to pause the future to fix the past. 🛑

We see this happen in MedTech all the time. A company receives a major audit finding or Warning Letter, and the immediate response is to shift critical R&D resources toward remediation.

Suddenly, your best engineers are pulled away from new product development to address legacy documentation, procedures, and quality system issues.

The impact?
🔹 Product launches are delayed
🔹 Innovation slows to a crawl
🔹 Valuable R&D resources become stretched thin

The most effective companies protect their R&D teams. They keep innovation moving forward by bringing in dedicated, specialized resources to manage the remediation efforts.

That’s where Warwick Consulting helps. Our experienced Quality and Regulatory professionals serve as your dedicated remediation resources, addressing compliance issues while your internal teams remain focused on innovation and your product pipeline.

Remediation requires focus and expertise, but it shouldn’t come at the expense of your future.
How does your organization balance the demand of legacy compliance cleanup with the need for new product development? Let us know below! 👇

08/12/2026

Everyone in MedTech is talking about AI right now, but let’s be honest, there are still a lot of questions about how to use it effectively and responsibly.

Because we work in a highly regulated industry, when a new technology operates inside a “black box,” Quality teams have to understand the risks and establish appropriate controls before moving toward full implementation.

But AI isn’t meant to replace your resources. It’s meant to help them work more efficiently by:
🔹 Reducing administrative burden
🔹 Accelerating complex data analysis
🔹 Giving them more time to focus on work that requires true expertise and human judgment

The question is no longer simply, “Should we use AI?”

It’s, “How do we use it responsibly and effectively?”

Is your organization already exploring AI within its QMS, or are you waiting for more regulatory guidance? Let us know below! 👇

07/29/2026

The Warwick Consulting team is heading to Cambridge, MA tomorrow evening!

Mansoor and Becky will be at the MassBio Summer Mixer at 100 Technology Square. We're looking forward to reconnecting with colleagues, meeting new people across the life sciences community, and exploring opportunities to collaborate.

If you'll be there, let us know in the comments or send us a DM, we'd love to connect and say hello! 👋

07/25/2026

When a critical supplier makes a mistake, what is their first instinct?

To pick up the phone and call you? Or to try to fix it quietly before you notice?

If it's the second one, you don't have a compliance problem, you have a trust problem. And in MedTech, that is where catastrophic quality issues usually start.

Under the FDA’s QMSR, your suppliers are considered to be a direct extension of your own manufacturing floor. But too many organizations manage them like a probation officer rather than a partner. We rely on rigid paperwork, self-surveys, and punitive clauses, creating an environment where suppliers are afraid to flag early warnings.

A Quality Agreement helps ensure both parties understand quality obligations. But open, transparent communication is what catches problems before they become customer issues.

The most resilient MedTech companies build supplier programs based on active collaboration:
🔹 Establishing realistic specifications together
🔹 Creating clear, non-punitive pathways for change notifications
🔹 Replacing "paper audits" with meaningful, risk-based oversight

At Warwick Consulting, we help MedTech leaders build supplier quality programs that balance strict regulatory compliance with real-world operational trust.
If your supplier program feels more like a paper shield than a working partnership, let's talk. Send us a DM to start the conversation. 🤝

Address

145 Longwood Avenue #2
Brookline, MA
02446

Telephone

+16175134121

Website

https://warwick.consulting/

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